Treatment for Non-Arteritic Ischemic Optic Neuropathy is
in Phase II/III Study
FREMONT, Calif., July 28, 2016 — Quark Pharmaceuticals, Inc. (“Quark”) today announced that the United States Patent and Trademark Office (“USPTO”) has granted a key patent covering the treatment of patients suffering from non-arteritic anterior ischemic optic neuropathy (“NAION”) with the Company’s ocular neuroprotectant QPI-1007. The patent will expire in 2033 with potential for term extension.
QPI-1007 received Orphan Drug status from the FDA for this indication and it is currently being evaluated in a global Phase II/III study, QRK207, to determine the effect of QPI-1007 on visual function in subjects with acute NAION. The QRK207 study is already enrolling in several countries, including the US and India with additional sites in Israel, Germany, Australia, Italy, and China opening soon. The clinical study is run by Quark in collaboration with Quark’s partners Biocon Ltd in India and the Chinese joint venture company of Quark in China, Kunshan RiboQuark Pharmaceutical Technology Co., Ltd.
“NAION is a serious condition, typically causing sudden vision loss without pain, the lack of treatment for this condition is a globally unmet medical need,” said Dr. Daniel Zurr, CEO of Quark. “Our drug, QPI-1007, has been shown in preclinical studies to be a neuroprotectant with a novel mechanism of action to block apoptotic cell death. We plan to expand the QPI-1007 program to additional ocular neuropathies that share the hallmark trait of retinal ganglion cell death, such as glaucoma.”
QPI-1007 is a double stranded RNA molecule chemically modified by Quark’s proprietary technology. The drug is designed to temporarily inhibit the expression of caspase 2 and thereby block the apoptotic death of retinal ganglion cells. QPI-1007 is being developed as a neuroprotectant for the treatment of NAION and in the future other optic neuropathies such as glaucoma that result in the death of retinal ganglion cells (RGCs). QPI-1007 has been evaluated in a human, dose escalation, Phase I/IIa Study (Protocol QRK007), delivered by single intravitreal injection to Optic Nerve Atrophy patients with low visual acuity and thereafter in acute NAION patients. This study was conducted at 22 sites in the US and 6 sites in Israel. This study showed that a single intravitreal injection of QPI-1007 was well tolerated in subjects with long-standing low vision or acute NAION. The drug has also demonstrated protective activity compared to historical data. QPI-1007 was also studied in a Phase IIa clinical trial in acute angle closure glaucoma patients in the United States, Vietnam and Singapore.
About Quark Pharmaceuticals, Inc.
Quark Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company, discovering and developing novel RNAi-based therapeutics for unmet medical needs. Two products, QPI -1002 for Delayed Graft Function (DGF) and QP -1007 for Non Arteritic Ischemic Optic Neuropathy (NAION) are in global phase III pivotal clinical studies, each of which was granted Orphan designation. The Company is also conducting several Phase II clinical trials. Quark’s broad pipeline of clinical and preclinical product candidates is generated by the company’s internally developed technology, which includes Quark’s RNAi platform technology and its delivery to a host of organs. Quark is headquartered in Fremont, California and operates research facilities in Ness-Ziona, Israel. For additional information please visit: www.quarkpharma.com.
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